BioTime to Begin Clinical Studies of PentaLyte, a New Blood Plasma Volume Expander.Business Editors/Health and Medical Writers BERKELEY, Calif.--(BW HealthWire)--April 18, 2000 BioTime, Inc. (AMEX AMEX See: American Stock Exchange :BTX (Balanced Technology EXtended) A motherboard design from Intel introduced in 2004 that supersedes the ATX. Unlike the ATX, the placement of all chip sockets in the BTX is defined in order to provide sufficient air flow over the processor and display adapter. ) announced today that it has received permission from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to begin a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of PentaLyte(R) involving nine subjects. PentaLyte is a proprietary pentastarch-based, physiologically balanced blood plasma blood plasma n. The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended. volume expander designed to replace blood volume in a variety of surgical applications. PentaLyte is the second in BioTime's family of products to enter clinical trials. Upon completion of this small safety study, BioTime plans to test PentaLyte in surgical procedures. PentaLyte contains a lower molecular weight hydroxyethyl starch hydroxyethyl starch see hetastarch. than Hextend(R), BioTime's lead product. PentaLyte is more quickly metabolized than Hextend, and is designed for use when short lasting volume expansion is desirable. "With both PentaLyte and Hextend, BioTime can look forward to more completely addressing the substantial market for blood plasma volume expansion," said Dr. Paul Segall, BioTime's Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Hextend, a plasma volume expander designed to replace large volumes of blood often lost during major surgery, is commercially available in the United States. Hextend has been submitted for approval in Canada. Chemistry, manufacturing, and control data are being compiled to complete the requirements to file for European approval. BioTime, headquartered in Berkeley, California, is engaged in the research and development of blood plasma volume expanders, blood replacement solutions during hypothermic (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and other applications. The matters discussed in this press release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated. Such risks and uncertainties include but are not limited to the results of clinical trials of BioTime products, BioTime's ability to obtain FDA and foreign regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for BioTime products; BioTime's ability to negotiate favorable foreign licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in BioTime products; and the availability of reimbursement for the cost of BioTime products and related treatment from government health administration authorities, private health coverage insurers and other organizations. These and other risk factors are discussed in BioTime's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission. |
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